Synthes (USA) Products LLC Recall 93924
Description: RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S
Synthes (USA) Products LLC Recall 93924 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1238-2024 |
| Event ID | 93924 |
| Event Description | RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa. |
| Quantity | 10 units |
| Recall Reason | Products not sterilized, sterility cannot be confirmed |
| Device Classification | 20240313 |
| Device Code Info | UDI: 10887587057262 Lot Number: 499P371 |
| Center Classification Date | 20240301 |
| Recall Initiation Date | 20240124 |
| Recalling Firm | Synthes (USA) Products LLC |
| Initial Notification | |
| Similar To |